MAUDE Adverse Event Report: KARL STORZ IMAGING CCU, MODULAR, IMAGE1 S CONNECT II, US

Model Number	TC201US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Cross reference mdrs: 2027009-2026-00163, 2027009-2026-00164, 2027009-2026-00165, 2027009-2026-00166, 2027009-2026-00168.
Additional Manufacturer Narrative
Additional information has been received as reflected in sections b1, b5, and h1.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).
Event or Problem Description
It was reported that "complete failure causing delayed surgery.Completely failed, no dashboard, no video signal out of any output".No negative impact in state of health reported.Additional information was received on 11-feb-2026.According to the additional information the procedure was delayed by one hour.Cross reference mdrs: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as completely failed, no dashboard and no video signal out of any output.The customer's reported complaint was verified with this device.This tc201us would not provide any output, and the fan was super loud.A functional test confirmed the customer's tc201us boot up issues and loud fan.The tc201us top cover was removed, and the following was observed: the fpga leds were off and so was the max_config_donen led.This indicates the cpld was unsuccessful in loading the fpga configuration files.Furthermore, mri-s310 was performed with following results: op10 power rails: passed, all voltages read good with standard fluke dmm.Op20 fpga clocks: passed, all clocks present (per mri - this isn't confirmation of clock integrity e.G., amplitude, or waveform integrity), just that the clocks are present.Measured with waverunner 9104 oscilloscope.Op30 fpga configuration pins: failed, conf_done led is low/off.Op40 quartus flash/cpld programming: passed, 100% success message reported.Op50 loading the config file directly into fgpa: failed, conf_done pin failed to go high error message.Op60 assign fpga file: n/a - no pass/fail criteria.This operation is the correlation table for the fpga files.Op70 quartus message: failed, see op50 above.Op80 corlies boundry scan: passed, fpga and da vinci test suite boundary scans passed without issue.Op90 troubleshooting guidance: n/a - no explicit pass/fail criteria in op.90, this lists how to interpretate the mri-s310 test results.Op100: end of operation: additional troubleshooting notes: the xi_clk_ddr4_2_265mhz had a low amplitude relative to other working tc201 units.The mri-s310 failures documented above strongly indicate that the fpga is not functioning, specifically, the failures detected in op.30 & 50.Ultimately, the customer's tc201us motherboard will need to be replaced to correct their reason for return.Tc201us motherboard information: 062821-05bb _ s/n: (b)(6).The cause of the issue was determined as cpld is unable to load the fpga files - fgpa is mostly like the cause.The event is filed under internal karl storz complaint id: (b)(4).Cross reference complaint ids: (b)(4).

• Brand Name: CCU, MODULAR, IMAGE1 S CONNECT II, US
• Common Device Name: CCU, MODULAR, IMAGE1 S CONNECT II, US
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta, ca 93117 ; GM 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24202931
• Report Number: 2027009-2026-00167
• Device Sequence Number: 13177182
• Product Code: FET
• UDI-Device Identifier: 04048551422625
• UDI-Public: 04048551422625
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TC201US
• Device Catalogue Number: TC201US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 03/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/18/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown